Some of the earliest known medical devices were being used in dental procedures between 7,500-9000 years ago in a Neolithic farming community from the Mehrgarh site (Indus Valley) in what is today, western Pakistan. Excavations of the site’s graveyard point to a...

Figure 1: Comparison of  European and US Conformity Assessment process of Medical Devices. Adapted from European law and United States law. Copyright 2020, Kvalito Consulting Group. The difference in the conformity assessment process between the European Union...

In response to the global pandemic of COVID-19, the FDA temporarily does not enforce supplier verification onsite audit requirement for receiving facilities and importers, if other supplier verification methods are used instead. This applies for an onsite audit in the...

“Once a new technology rolls over you, if you're not part of the steamroller, you're part of the road.”—Stewart Brand Health Technology is defined by the World Health Organization (WHO) as “the application of organized knowledge and skills in the form of devices,...